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VectraCor ABPM-05

Device Name:ABPM-05
Manufacturer:

OBL: VectraCor Inc., 785 Totowa Road, Totowa, New Jersey 07512, UNITED STATES.

OEM: Meditech Ltd., Mikszath Kalman utca 24, 1184 Budapest, HUNGARY.

Measuring functions:Blood pressure
Primary Client Use:Intended for ambulatory blood pressure monitoring
Measurement Site:Upper Arm
Measurement Occurrence:Intermittent measurements at specified intervals or times
Availability:Available Currently
Assessment:

There appears to be no peer-reviewed clinical validation information available on the technology used in the VectraCor ABPM-05 to measure blood pressure. However, this device appears to be very similar to a validated device by the same (OEM) manufacturer but equivalence needs to be proven according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Accuracy AssessmentRecommendationBasis
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.

Device Family:BIOS ABP-01Z, BTL Cardiopoint BTL-08 ABPM (V1)B, Meditech ABPM-04B,D, Meditech ABPM-05B,D, Meditech card(X)ploreD, Omron M24/7 (ABPM-BP5)B, VectraCor ABPM-05Z (B BIHS Derivative, D DET Equivalence, Z Almost Certain)
Validation Publications for Equivalent Devices

Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.

Meditech ABPM-04

Barna I, Keszei A, Dunai A. Evaluation of Meditech ABPM-04 ambulatory blood pressure measuring device according to the British Hypertension Society protocol. Blood Press Monit. 1998;3(6):363-8. PMID: 10212378.

BHS:1993 - Pass (B/B) General population

SP10:1992 - Pass General population